Speid & Associates, Inc.

	Regulatory Affairs
	Drugs, Gene Therapy, Devices, Diagnostics Biologics
	Communications with all major Health Authorities
	Development of regulatory and drug development strategy
	Global regulatory affairs
	Collation and organization of health authority correspondence
	Function as consultant VP Regulatory Affairs
	Appeals
	Organization of dispute resolution process
	Perform critical reviews of prepared submissions
	European clinical trial applications
	CTAs, INDs, CTXs, NDAs, CTDs, MAAs
	Strategic planning
	Annual Report preparation (INDs, approved products)
	Summary Basis of Approval review and analysis

	Clinical Research and Operations
	Medical writing
	Protocol design
	Clinical trial design
	Clinical trial monitoring (through collaborator monitors throughout the country) and abroad

	Quality Assurance
	Development of quality strategy
	Development of quality systems
	Training of senior management in quality concepts
	Audits of suppliers, manufacturers, toxicology houses, etc
	Preparation for pre-approval inspections
	Performance of mock-FDA inspections

	Drug Safety
	Development of corporate strategy on safety
	Preparation of safety reports
	Liaison with investigative sites and CROs for development of SOPs for drug safety
	Training in drug safety concepts

	Chemistry Manufacturing Controls
	Manufacturing strategy for drug substance and drug product

Due Diligence Services for Venture Capitalists

Some life science investments pay off, while others do not. A good regulatory and drug development due diligence assessment before you sign that check can reduce the risk of a failed investment. To participate in a verbal (anonymized) survey which is evaluating the reasons some investments are successful and others are not, contact lspeid@sndtm.com

Legal Affairs

Lorna has partnered with a prominent San Diego attorney to provide legal affairs services including contract review, FDA law consulancy, and related services. Write to legal@sndtm.com for more information.

Corporate Governance

Lorna has partnered with experts to provide services in corporate governance, including situational ethics, organizational structure, Sarbanes Oxley compliance, hiring right, etc. Write to governance@sndtm.com for more information.

Team Development and Growth

Demotivated team that is not working well together? Contact us to see how you can get them back on track.